| TGA Action ID |
RC-2025-RN-00028-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
FRAXIS laser systems and associated Lotus accessories
FRAXIS CO2 Laser System
Product code: CAP-FRAXIS
FRAXIS DUO CO2 Laser RF System
Product code: CAP-FRAXISDUO
Lotus Gynolaser
Product code: CAP-FRX-GYNO
Lotus i-Slide
Product code: CON-LOTUS-ISLIDE
ARTG's 273658, 273659, 289656, 289657 |
| ARTG Number |
273658, 273659 |
| Action Type |
Recall / Product Correction |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
The TGA has completed a post-market review of all energy-based devices used for vaginal rejuvenation included in the Australian Register of Therapeutic Goods (ARTG). The review found there was insufficient clinical evidence to support the therapeutic use and long-term safety of these devices.
The genitourinary and vaginal rejuvenation indications for the FRAXIS and FRAXIS DUO laser system are no longer approved by the TGA. The Instructions For Use (IFU) have been updated to reflect the reduced indication.
The associated accessories, Lotus Gynolaser and i-Slide, were cancelled from the ARTG as they are no longer approved for their intended purpose.
No injuries or safety related adverse events were reported. |
| Instructions for Customers/Users |
Customers are to:
- Return the Lotus Gynolaser and i-Slide
- Review the new IFU for the FRAXIS and FRAXIS DUO laser system. |
| Action Commencement Date |
17/03/2025 |
| Responsible Entity |
|
| Contact Information |
1300 346 448 - Cryomed Customer Service |